Evaluation of innovations in healthcare
British Healthcare Chooses Innovation
Natalia Kharlamova, <url>
How a new drug enters the market in the public health system of England, how the value of innovation and the quality of life of patients are measured in medicine – the participants of the seminar "Assessment of innovations in Healthcare", organized by the biomedical cluster of the Skolkovo Foundation together with the National Institute for Health Improvement of Great Britain (NICE), learned about this and much more.
On February 6, representatives of biomedical startups, developers of pharmaceutical products, medical devices and diagnostics gathered in the library of the Skolkovo Technopark to understand how innovative medical technologies are being introduced at the state level in England. The seminar's presenters, Elizaveta Osipenko, Director of the Scientific Council of the National Institute for Health Improvement of Great Britain (NICE), and Grace Jennings, technical adviser of the same institute, spoke about the possibility of bringing the product to the British market.
Kirill Kaem, Vice President and Executive Director of the biomedical technologies cluster of the Skolkovo Foundation, made a welcoming speech and recalled that the foundation's activities are becoming "the driving force of changes in the state." "Speaking of commercialization, we continue to insist that the project must be commercialized not only in Russia, but also abroad," he stressed.
At the same time, the experience of the UK will help formulate the goals of projects in such a way as to facilitate this task, as well as create the right requests for changing legislation, Kirill Kayom believes.
According to Elizaveta Osipenko, technology assessment in healthcare is a new experience for all countries, and the methodology of this assessment continues to develop both from the clinical and economic side. "The system of technology assessment in healthcare appeared for a simple reason – there is not enough money. Financing is never enough, people always want to receive more new services and new drugs," Osipenko explained.
In Europe, the healthcare budget is limited. Thus, the budget of the health system in England is about 95 billion pounds for 53 million people. He must cover all services – from a band-Aid in the therapist's office to the salary of a neurosurgeon. The introduction of expensive new drugs or devices requires a redistribution of the budget and the rejection of any other services or expenditure items. "People who make decisions take risks, they manage taxpayers' money. An incorrectly made decision will lead to discontent and criticism from the public," Osipenko said.
NICE is a little over 15 years old. Founded in 1999 by Tony Blair, the institute was created with the aim of evaluating new medicines (HTA – Healthcare Technology Assessment), eliminating inequalities in access to new drugs in different parts of England, setting quality standards and monitoring the effective use of taxpayer funds. The Institute reports directly to the Minister of Health. At the same time, the Ministry of Health partially defines the tasks of the institute, but cannot veto NICE's decisions.
The European Medical Agency (EMA), like the American FDA (the Federal Agency for the Control of the Pharmaceutical and Food Market in the USA), issues a license for new pharmaceuticals, checking clinical research data – this is a little more than 200 licenses per year. Of these, about 50 are innovative drugs.
NICE estimates about 40 pharmaceuticals per year. The competence of the Institute includes innovative products and existing medical technologies, the decision on which is reviewed every three years. NICE review begins well before obtaining a license in order to issue a preliminary recommendation for the drug within 4 months after obtaining a license. The whole process can take 12-18 months.
The assessment of innovations in NICE boils down to two questions: how much better the proposed technology works in comparison with the existing practice of the National Health Service of the United Kingdom, and how much treatment using the new technology costs relative to the established practice.
"The selection of pharmaceuticals for evaluation in NICE goes through an official procedure and is signed by the minister. Developers of devices and diagnostics themselves can submit an application for product evaluation to the institute. If it is interesting enough and has a good evidence base, then it can be selected for evaluation," Elizaveta Osipenko clarified.
NICE's positive recommendation on the pharmaceutical guarantees funding across England. However, a positive recommendation on a device or diagnostics does not guarantee financing, but is an important document proving the advantages of the product and helping companies with further promotion of their technology in England and other markets.
Much attention is paid to the scientific evidence base based on the conducted tests, the provision of which is a prerequisite for submitting an application for product evaluation. The decision to include a product in the healthcare system and provide it with state support is influenced by all participants in the process: from patients to pharmaceutical companies. All information about the evaluation process for each technology is presented on the Institute's website.
Having introduced the audience to the programs for evaluating medical devices and pharmaceuticals that exist in NICE, Technical Adviser Grace Jennings clarified that the expert panel of final decision makers consists of practitioners of the public health system, including economists; patients or their representatives, pharmaceutical companies and the public; 1-2 specialists in a specialized technological direction. The assessment is carried out both from the clinical and economic side. All data from the manufacturer is checked by an academic group and the results, as well as the original data, are submitted to the NICE decision-making committee.
If you plan to declare your medical device for evaluation in NICE, it is useful to express its value in specific statements. "It is very important to think about your product and choose those value propositions about which you can say, for example, "I halve the doctor's time, I have conducted tests, here are my proofs," rather than making general statements about the benefits of the product," she told about approaches to determining the value of innovative drugs and devices Elizaveta Osipenko. At the same time, patient reviews represent important qualitative information, which in itself is insufficient for decision-making. Undoubtedly, the low cost of development is also attractive.
It is worth considering that NICE does not single out priority areas of research and is guided by the law of equality: the institute does not raise the question of who is more important, a young society or happy old people. From the point of view of the UK healthcare system, everyone should have the same access to the healthcare system.
For NICE, it is not enough to describe the impact of a new medical drug/technology on the biological indicators of patients, the principal interest of the institute is the results related to quality and life expectancy and, of course, the economic feasibility of innovation – is it worth paying the price requested by the manufacturer for an additional effect.
To measure the effectiveness of the new drug, NICE and other European agencies use the quality of life assessment using the EQ-5D tool. It is based on a questionnaire evaluating 5 parameters: the ability to move independently, to take care of oneself, to perform daily duties (study, work, etc.), the presence of pain and discomfort, emotional state (involvement – depression). According to the results of calculations using a certain formula, the state of health is estimated from 0 (death) to 1 – a completely healthy person. The value of the new technology is calculated through the QALY – Quality Adjusted Life Year index, a year of life adjusted for the quality of life.
The use of QALY provides a common denominator for comparing different drugs and allows you to decide which of them will be justified, given the limited state budget and focus on quality of life.
Grace Jennings described the logic and methodology of data collection for evaluating healthcare technologies. The evidence base of clinical product development is based on 4 components: a sample of patients for whom the drug/technology is designed; the technology or product itself; the standard of treatment used in practice in the National Health Service at the moment (to compare a new drug); the effects of the drug/technology affecting the survival and quality of life of the patient.
Elizaveta Osipenko also spoke about the activities of a separate division of the institute – the NICE Scientific Council, which was formed in 2009. Its function is to answer questions from pharmacological/biotech companies about the introduction of innovative drugs/devices/tests to the British market. The best time for companies to come for advice is before the key tests of phase 2 or 3 begin, during the formulation of plans for the creation of a product, before obtaining a license. After all, a license from the regulator does not guarantee sales and state compensation, this is only the first step of entering the market. Scientific advice from OTP agencies helps developers prepare an evidence base that meets the requirements of both the regulator and the payer.
"The advice is paid, the logic is simple – taxpayers' money should not be used to advise a company that may decide not to bring its product to the market for patients in England," the director of the scientific council clarified. For small, less than 250 people, companies, the advice of the council will cost 15 thousand pounds, for large – about 30-50 thousand pounds. There is also a model of a parallel scientific council with the European Medical Agency and national European OTZ agencies.
At the same time, a new program is working in Britain to bring the drug to the market before licensing, with a special permit. So, the first product to receive such a permit is a regenerative medicine drug for the treatment of gliomas, brain tumors that increase the life expectancy of patients by 2.5 times.
Portal "Eternal youth" http://vechnayamolodost.ru11.02.2015